SYMPHONY 2020-00-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705034532776), received between Jan 22, 2020 and Sep 15, 2026 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (46 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781553 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781552 ↗
• MalfunctionNov 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREWDRIVER SLEEVE AND SHAFT CAN NOT BE INSERTED TOGETHER. EVENT OCCURRED DURING SURGICAL SET UP. PROCEDURE WAS COMPLETED WITH NO IMPACT AS A BACK UP DEVICE WAS USED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534727 ↗
• MalfunctionSep 11, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN THE ITEM WAS USED DURING SURGERY, THE LOWER PART OF THE KNOB CAME LOOSE WHEN A SCREW WAS INSERTED AND THE SCREWDRIVER WAS TO BE REMOVED FROM THE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23029671 ↗
• MalfunctionSep 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TWO OF THE SCREWDRIVERS ON THE SYMPHONY SET ARE DISENGAGING FROM THE SCREWDRIVERS DUE TO THE SCREWDRIVER TIPS BEING WORN. THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES. THIS CAUSED A SLIGHT DELAY IN OPERATING TIME AS WE HAD TO OPEN ANOTHER KIT BUT DID NOT HAVE ANY ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007367 ↗
• MalfunctionSep 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT TWO OF THE SCREWDRIVERS ON THE SYMPHONY SET ARE DISENGAGING FROM THE SCREWDRIVERS DUE TO THE SCREWDRIVER TIPS BEING WORN. THE INSTRUMENT DID NOT BREAK INTO TWO OR MORE PIECES. THIS CAUSED A SLIGHT DELAY IN OPERATING TIME AS WE HAD TO OPEN ANOTHER KIT BUT DID NOT HAVE ANY ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007351 ↗
• MalfunctionJun 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRIVER AND RETENTION SLEEVE WERE NOT WORKING. DRIVER WAS GETTING CAUGHT IN RETENTION SLEEVE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175167 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION ON (B)(6) 2025, THE BARREL ON A SYMPHONY RETENTION SLEEVE BROKE AS THE SURGICAL TECH WAS ATTEMPTING TO LOAD A SCREW FROM THE CADDY. THE DAMAGED DRIVER WAS REMOVED FROM THE FIELD AND A BACKUP WAS USED. THIS EVENT DID NOT CAUSE ANY DELAY IN SURGERY OR ANY NEGATIVE IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775764 ↗
• MalfunctionDec 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2024 THE SYMPHONY POLYAXIAL DRIVERS AND SLEEVES WERE BECOMING INCREASINGLY STIFF DESPITE LUBRICATION. THE SECOND DRIVER FROM SET WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20820021 ↗
• MalfunctionOct 15, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024. NURSE AND SURGEON WERE HAVING DIFFICULTY LOADING ONE OF THE DRIVERS FROM THE SYMPHONY SET. IT APPEARS AS THOUGH THE THREADS MAYBE DAMAGED, CAUSING DIFFICULTIES WITH THE RETENTION SLEEVE TO THREAD PROPERLY TO THE DRIVER. CASE WAS COMPLETED SUCCESSFULLY WITH THE SECOND DRIVER FROM THE SET WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450663 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT HAD A BROKEN SPRING POSTOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19023043 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PROCEDURE ON MARCH 4, 2024, THE SPRING ON THE BARREL OF A SYMPHONY RETENTION SLEEVE BROKE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940114 ↗
• MalfunctionOct 9, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE THREADS TO BE SCREWED INTO THE SCREWHEAD HAVE BROKEN DISTALLY ON THE FIRST THREAD. IT WAS NOT POSSIBLE TO TURN ON THE SCREW AND USE THE SCREWDRIVER. THERE WAS A TWENTY (20) MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A SAME LIKE PRODUCT. THIS REPORT INVOLVES ONE (1) SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17896391 ↗
• MalfunctionSep 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SYMPHONY DRIVER SHAFT AND OUTER SLEEVE BECAME STUCK TOGETHER. IT WAS ALMOST IMPOSSIBLE TO SEPARATE. DRIVER POSSIBLY WAS BENT. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) POLY SCREW DRIVER RETEN SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821892 ↗
• MalfunctionSep 11, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING PRE-OP ON (B)(6) 2023, THE DRIVER AND SLEEVE IN QUESTION WERE STICKING AND GETTING STUCK. THE DRIVER SHAFT WAS FOUND TO BE BENT, AND BURRS WERE FOUND INSIDE OF THE DRIVER SLEEVE. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING, FIELD INSPECTION, NOR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719187 ↗
• MalfunctionMay 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT BOTH POLYAXIAL SCREW DRIVER SHAFT X20 FROM SYMPHONY COULDN'T FIT PROPERLY THE SCREWS. THE SCREWS WERE NEVER WELL COUPLED WITH THE DRIVER SHAFT, NEITHER STRAIGHT. BOTH SCREW DRIVER SHAFT WERE DIFFICULT TO INSERT IN THE POLYAXIAL SCREW DRIVER RETENTION SLEEVES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 180 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1)POLY SCREW DRIVER RETEN SLEEVE. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17024014 ↗
• MalfunctionMay 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT BOTH POLYAXIAL SCREW DRIVER SHAFT X20 FROM SYMPHONY COULDN'T FIT PROPERLY THE SCREWS. THE SCREWS WERE NEVER WELL COUPLED WITH THE DRIVER SHAFT, NEITHER STRAIGHT. BOTH SCREW DRIVER SHAFT WERE DIFFICULT TO INSERT IN THE POLYAXIAL SCREW DRIVER RETENTION SLEEVES. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 180 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) POLY SCREW DRIVER RETEN SLEEVE. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17023931 ↗
• MalfunctionMay 23, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING ASSEMBLY FOR A CASE, IT WAS NOTED BY THE SCRUB NURSE AND LATER CONFIRMED BY REP THAT ONE OF THE X20 SCREWDRIVER AND SLEEVE DID NOT ASSEMBLE PROPERLY. THE SHAFT GAVE SIGNIFICANT RESISTANCE WHEN BEING INSERTED THROUGH SLEEVE. THE SHAFT APPEARS TO BE SLIGHTLY BENT, CAUSING ISSUES WHEN TRYING TO PASS THROUGH SLEEVE. BOTH SHAFT AND SLEEVE SET ASIDE AND NOTE USED. NAVIGATED DRIVERS WERE USED, NO CASE IMPACT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) POLY SCREW DRIVER RETEN SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989228 ↗
• MalfunctionMar 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SCRUB NURSE HAD PROBLEMS LOADING EACH OF THE 4 SCREWS STRAIGHT FOR IMPLANTATION, 2 DIFFERENT SCREW DRIVERS WERE TRIED AND SAME ISSUE WITH BOTH SCREWDRIVERS ON THE SET. NURSE PERSEVERED IN ATTEMPTING TO LOAD THE SCREW STRAIGHT. THIS DELAYED THE LENGTH OF THE SURGERY BY APPROXIMATELY 10 MINUTES. THERE IS NO INDICATION THAT THE TIME DELAY OCCURRED AT A CRITICAL PROCEDURE STEP WHERE HIGH RISKS TO THE PATIENT MAY BE PRESENT. THERE IS NO INDICATION THAT THE DELAY RESULTED IN ANY IMPACT TO THE EXPECTED SURGICAL OUTCOME. THIS REPORT IS FOR ONE (1) POLY SCREW DRIVER RETEN SLEEVE THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577045 ↗
• MalfunctionMar 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SCRUB NURSE HAD PROBLEMS LOADING EACH OF THE 4 SCREWS STRAIGHT FOR IMPLANTATION, 2 DIFFERENT SCREW DRIVERS WERE TRIED AND SAME ISSUE WITH BOTH SCREWDRIVERS ON THE SET. NURSE PERSEVERED IN ATTEMPTING TO LOAD THE SCREW STRAIGHT. THIS DELAYED THE LENGTH OF THE SURGERY BY APPROXIMATELY 10 MINUTES. THERE IS NO INDICATION THAT THE TIME DELAY OCCURRED AT A CRITICAL PROCEDURE STEP WHERE HIGH RISKS TO THE PATIENT MAY BE PRESENT. THERE IS NO INDICATION THAT THE DELAY RESULTED IN ANY IMPACT TO THE EXPECTED SURGICAL OUTCOME. THIS REPORT IS FOR ONE (1) POLY SCREW DRIVER RETEN SLEEVE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577039 ↗
• MalfunctionMar 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING ARTHRODESIS C1-C3 FIXATION ON (B)(6) 2023, THE SCRUB NURSE HAD PROBLEMS LOADING EACH OF THE 6 SCREWS STRAIGHT FOR IMPLANTATION. TWO DIFFERENT SCREW DRIVERS WERE USED, AND BOTH EXPERIENCED THE SAME ISSUE. THIS DELAYED THE LENGTH OF THE SURGERY BY APPROXIMATELY 10 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572754 ↗
• MalfunctionMar 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING ARTHRODESIS C1-C3 FIXATION ON (B)(6) 2023, THE SCRUB NURSE HAD PROBLEMS LOADING EACH OF THE 6 SCREWS STRAIGHT FOR IMPLANTATION. TWO DIFFERENT SCREW DRIVERS WERE USED, AND BOTH EXPERIENCED THE SAME ISSUE. THIS DELAYED THE LENGTH OF THE SURGERY BY APPROXIMATELY 10 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572752 ↗
• MalfunctionJan 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JANUARY 3, UPON ROUTINE INSPECTION DEFICIENCIES WERE NOTED WITH BOTH SYMPHONY SCREW DRIVERS AND DRILL GUIDES: 2X SCREW DRIVER SHAFTS DIFFICULT TO INSERT AND THEN FREEZING INSIDE DRIVER RETENTION SLEEVE IN SPITE OF NUMEROUS CLEANING AND LUBRICATION. 2X SYMPHONY DRILL GUIDE ADJUSTABLES DIFFICULT TO INSERT AND THEN LOCKING UP INSIDE THE GUIDE BODY IN SPITE OF NUMEROUS CLEANING AND LUBRICATION. THERE WERE NO PATIENT OUTCOMES/CONSEQUENCES. THERE WERE NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) POLY SCREW DRIVER RETEN SLEEVE. THIS IS REPORT 4 OF 4 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230402 ↗
• MalfunctionJan 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JANUARY 3, UPON ROUTINE INSPECTION DEFICIENCIES WERE NOTED WITH BOTH SYMPHONY SCREW DRIVERS AND DRILL GUIDES: 2X SCREW DRIVER SHAFTS DIFFICULT TO INSERT AND THEN FREEZING INSIDE DRIVER RETENTION SLEEVE IN SPITE OF NUMEROUS CLEANING AND LUBRICATION. 2X SYMPHONY DRILL GUIDE ADJUSTABLES DIFFICULT TO INSERT AND THEN LOCKING UP INSIDE THE GUIDE BODY IN SPITE OF NUMEROUS CLEANING AND LUBRICATION. THERE WERE NO PATIENT OUTCOMES/CONSEQUENCES. THERE WERE NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) POLY SCREW DRIVER RETEN SLEEVE. THIS IS REPORT 2 OF 4 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230398 ↗
• MalfunctionNov 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SYMPHONY SCREWDRIVERS IN QUESTION WERE BINDING UP DURING ASSEMBLY. ON CLOSER INSPECTION IT WAS FOUND TO BE DIFFICULT TO PASS THE DRIVER SHAFT THROUGH THE DRIVER SLEEVE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868854 ↗